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Study Evaluating Sirolimus in Kidney Transplant Recipients

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Graft vs Host Disease
Kidney Transplantation

Treatments

Drug: cyclosporine
Drug: daclizumab
Drug: sirolimus
Drug: mycophenolate mofetil
Drug: corticosteroids

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195273
0468H-101466

Details and patient eligibility

About

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Kidney transplantation
  • Donor must be at least 60 years old.

Exclusion criteria

  • Current systemic infection
  • Unstable angina or treatment for serious arrhythmia.
  • Cancer within the previous 5 years.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

61 participants in 2 patient groups

1
Experimental group
Description:
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
Treatment:
Drug: mycophenolate mofetil
Drug: daclizumab
Drug: sirolimus
Drug: corticosteroids
2
Active Comparator group
Description:
Cyclosporine + Mycophenolate + Corticosteroids
Treatment:
Drug: mycophenolate mofetil
Drug: corticosteroids
Drug: cyclosporine

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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